Title: CMC Document Specialist Reports to: Junior Manager R&D Quality Assurance and Technical Documentation The CMC Documentation Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by supporting the documentation activities for regulatory submissions for pharmaceutical, veterinary and NHP products as part of Biolab\xe2\x80\x99s CMC Strategies. The CMC Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations (Health Canada, ANVISA, FDA, others) in a timely manner while complying with departmental SOP\'s and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonisation). This will be achieved by working very closely with the analytical development, formulation development and R&D QA teams. This role requires effective collaboration across technical functions to deliver on timelines for submissions. Key job responsibilities and duties:
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